Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol

Phase 4

Terminated

• Conditions: Hemostatic Disorders
• Interventions: Other: Group C; Procedure: Group ROTEM

• Registration Number: NCT01919840
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Main objective:

Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.

Design:

Prospective randomized controlled trial and single blinded.

Disease or disorder under study:

Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Primary endpoint:

median transfusion of packed red blood cells per patient. Study population Male and female patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed excessively.

Duration of treatment:

The coagulation monitoring methods tested are made from protamine administration to CEC output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied critics a) bleed excessively drains and until the patient stops bleeding (debit drains \<a 150ml / h).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2013-04-12
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-08
• Last Update Submitted: 2013-08-08
• Study First Posted: 2013-08-09
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Male and female patients
• over 18 years
• undergoing cardiac surgery
• with cardiopulmonary bypass
• bleed excessively

As it is not possible to predict in advance who will bleed, informed consent will be required for all patients over 18 who are to undergo cardiac surgery with CPB.

Will be randomized to either group

1. Those patients with diffuse bleeding after protamine administration. and / or
2. They bleed excessively after surgery. Are excessive bleeding criteria: the debit ≥ 300ml drains in the first hour; ≥ 250ml in the second hour or ≥ 150ml at any later time. Consider that the patient is bleeding excessively when the drains debit is <150ml.

Exclusion Criteria

• Patients <18 years
• Extracorporeal circulation surgery
• Surgery with Mini extracorporeal circulation (MECC)
• Refuse to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Group C	• conventional protocol, volume replacement with massive bleeding.
Group ROTEM	Group ROTEM	• Protocol according to the different tests to be performed with thromboelastography

Primary Outcome Measures

Name	Time	Method
median transfusion of packed red cells per patient	24 hours

Secondary Outcome Measures

Name	Time	Method
rate transfusion of platelets pool and plasma pool	24 hours